Ever since the World Health Organization (WHO) has declared the COVID-19 outbreak as a pandemic, the global health authorities and life sciences organizations are quickly responding to the situation to see how they can make meaningful contributions.
Given the significance of ‘Testing’ in these extraordinary times and to align with the increasing demand for more COVID-19 diagnostic kits across the globe, a few of the global health authorities are expediting their Regulatory approval processes for the IVD kits. One among them is the Central Drugs Standard Control Organization (CDSCO) - India’s Regulatory body, which has taken quick measures to support companies, which are either developing an In-vitro Diagnostic (IVD) kit or which have an existing one already approved by either the USFDA or the EMA. Any application submitted to the CDSCO will be processed on high priority.
Though the approval process is expedited, the scrutiny is expected to be as stringent as before to protect the safety and to serve the cause of controlling COVID 19. The IVD kits shall undergo expedited review and accelerated approval process with abbreviated, deferred or waived off data requirements including clinical requirements depending on the type of kit, existing data, and evidence of clinical performance data.
To gain the Indian market access, IVD kit manufacturers might be exploring ways to rapidly upscale their production. Prior to that, it is essential to acquire requisite permissions on time to register their products and obtain faster approvals for early circulation. How prepared are you to compile the dossier, to interact with the CDSCO to obtain requisite permissions, to submit the application for on time registration? Don’t Leave it to chance. Consult an expert. Stay safe. Stay informed. Stay compliant.